Mono-layer electrode sensor

Abstract

A mono-layer electrode sensor suitable for a multitude of electrophysiology testing applications is disclosed. The electrode sensor can include a mono-layer of conductive film shaped with a soft-form geometry that is modifiable to a targeted size tailored to a patient. The conductive film includes a sensing area that is complementary to a size and morphology of a body structure of the patient. The conductive film can have a connector coupled to the sensor, and the skin adherent side can have a bio-compatible hydrogel coated there over including a non-conductive material formed over the connector portion of the conductive film.

What is claimed is: 
     
       1. An electrode sensor, comprising:
 a mono-layer of conductive film, the conductive film having a first side adapted for placement facing an anatomical site of a patient and a second side, opposing the first side, having direct exposure to an ambient environment of the patient, wherein a size and shape of the conductive film define an entire size and shape of the electrode sensor in a plan view, wherein the conductive film includes a sensing area that is modifiable to a targeted size and defined by at least one concave curved outer edge of the conductive film configured to be complementary to a morphology of a body structure of the patient that is proximate the anatomical site, the sensing area adapted to collect electrical signal representations of electrophysiological electrical energy generated from the body structure and generate signal representations thereof; and 
 a connector coupled to the conductive film for connection to an electrophysiological device; a non-conductive material located adjacent to only a portion of the first side of the conductive film, wherein the non-conductive material extends along the first side of the conductive film beyond a perimeter of the connector, with one end of the non-conductive material being in vertical alignment with a first end of the conductive film and another opposing end of the non-conductive material extending along the first side of the conductive film to a mid-region thereof, wherein the non-conductive material overlays the connector and only the first side of the conductive film extending from the first end to beyond the perimeter of the connector to the mid-region. 
 
     
     
       2. The electrode sensor of  claim 1 , wherein the conductive film includes a carbon conductive film impregnated with a silver conductive treatment. 
     
     
       3. The electrode sensor of  claim 2 , wherein the silver conductive treatment includes Ag/AgCl. 
     
     
       4. The electrode sensor of  claim 1 , wherein the connector includes a base portion formed on the conductive film and a projection element supported by the base portion that extends outward through the conductive film and the base portion. 
     
     
       5. The electrode sensor of  claim 1 , further comprising a bio-compatible hydrogel coated over the first side of the conductive film and the non-conductive material, wherein the non-conductive material separates the hydrogel from direct contact with the connector. 
     
     
       6. The electrode sensor of  claim 5 , wherein the bio-compatible hydrogel comprises an Ag/AgCl hydrogel. 
     
     
       7. The electrode sensor of  claim 1 , wherein the sensing area of the conductive film is modifiable to the targeted size by trimming a portion thereof. 
     
     
       8. The electrode sensor of  claim 1 , wherein the conductive film is shaped with a soft-form geometry including a curvilinear shape. 
     
     
       9. The electrode sensor of  claim 1 , wherein the first side of the conductive film further includes a non-sensing area outside of the sensing area, and wherein the connector is surrounded by the non-sensing area, offset from the sensing area. 
     
     
       10. An electrode sensor, comprising:
 a mono-layer of conductive film that is continuously conductive from a first end to an opposing second end, the conductive film having a first side adapted for placement facing an anatomical site of a patient and a second side, opposing the first side, the conductive film including a large sensing area located proximate to the second end and shaped with a curvilinear geometry that is modifiable to a targeted size, wherein a size and shape of the conductive film defines an entire size and shape of the electrode sensor in a plan view, wherein the large sensing area is partially defined by a concave curved outer edge of the conductive film, a convex curved outer edge of the conductive film parallel to the concave curved outer edge, and a rounded second end of the conductive film, and wherein the large sensing area is adapted to collect electrical signal representations of electrophysiological electrical energy generated from a body structure of the patient and generate signal representations thereof; 
 a connector coupled to the conductive film proximate the first end, wherein the connector includes a base portion formed on the first side and the second side of the conductive film and a projection element supported by the base portion that extends outward through the second side of the conductive film; 
 a non-conductive material located adjacent to only a portion of the first side of the conductive film, wherein the non-conductive material extends along the first side of the conductive film beyond a perimeter of the connector to define a non-sensing area of the conductive film; and 
 a hydrogel coated over the first side of the conductive film and the non-conductive material, wherein the non-conductive material separates the hydrogel from direct contact with the connector. 
 
     
     
       11. The electrode sensor of  claim 10 , wherein the conductive film includes a carbon conductive film impregnated with a silver conductive treatment, wherein the silver conductive treatment includes Ag/AgCl. 
     
     
       12. The electrode sensor of  claim 10 , wherein the hydrogel comprises Ag/AgCl. 
     
     
       13. The electrode sensor of  claim 10 , wherein the large sensing area is complementary to a size and morphology of a tissue or organ, located on a face, head, or an eye of the patient, and wherein the conductive film is a carbon conductive film having a thickness up to about 5 mils. 
     
     
       14. The electrode sensor of  claim 10 , wherein the large sensing area of the conductive film provides at least partial circumference coverage of the body structure. 
     
     
       15. The electrode sensor of  claim 10 , wherein the large sensing area provides complete coverage of the size, the location and the morphology of the body structure. 
     
     
       16. The electrode sensor of  claim 10 , wherein the large sensing area encompasses about 25% to about 50% of a total surface area occupied by the conductive film and the connector. 
     
     
       17. The electrode sensor of  claim 10 , wherein the non-sensing area has an elliptical shape. 
     
     
       18. An electrode sensor for detecting electrophysiological electrical energy generated from an anatomical site of a patient, comprising:
 a mono-layer of conductive film having a first side adapted for placement facing the anatomical site of the patient and a second side, opposing the first side, having direct exposure to an ambient environment of the patient at least in a sensing area of the conductive film, wherein the conductive film is a carbon conductive film having a thickness up to about 5 mils and a size and shape of the conductive film define an entire size and shape of the electrode sensor in a plan view, the conductive film shaped with a rounded rectangular geometry that is modifiable to a targeted shape that is tailored to the patient, the sensing area adapted to collect electrical signal representations of electrophysiological electrical energy generated from a body structure located on a face, head, or an eye of the patient and generate signal representations thereof; 
 a connector coupled to the conductive film, wherein the connector includes a base portion formed on the first side and the second side of the conductive film and a projection element supported by the base portion that extends outward through the second side of the conductive film; 
 a non-conductive material overlaying only a portion of the first side of the conductive film corresponding to the connector, wherein the non-conductive material defines a non-sensing area of the conductive film; and 
 a hydrogel coated over the first side of the conductive film and the non-conductive material, wherein the non-conductive material separates the hydrogel from direct contact with the connector. 
 
     
     
       19. The electrode sensor of  claim 18 , wherein the conductive film includes a carbon conductive film impregnated with a silver conductive treatment. 
     
     
       20. The electrode sensor of  claim 18 , wherein the hydrogel comprises Ag/AgCl.